Personal Sound Amplification Smartphone Application Feasibility

NCT03652909 | Completed Results

• 2 other identifiers: PRO00032080R41DC017939
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Find a personal sound amplification device that can help people hear better.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

• Sentence Perception in Noise Fine-tuned v Unamplified

  The fine-tuned Personal Sound Amplification Device sound output will show speech perception benefit over the unamplified condition. Measure is percent of words heard correctly.

  The patient will wear the Personal Sound Amplification Device for approximately 30 minutes

• Sentence Perception in Noise Initial Fit v Unamplified

  The prescription gain (initial fit) Personal Sound Amplification Device sound output will show speech perception benefit over the unamplified condition. Measure is percent of words heard correctly.

  The patient will wear the Personal Sound Amplification Device for approximately 30 minutes

Secondary Outcomes (3)

• Words Clear

  The patient will wear the personal sound amplification device on average for 30 minutes.

• Sentences Easy to Understand

  The patient will wear the Personal Sound Amplification Device for approximately 30 minutes

• Sounds Are Distorted

  The patient will wear the Personal Sound Amplification Device for approximately 30 minutes

Study Arms (1)

Adults with difficulty hearing in some daily listening situations

Patients listen to sounds with and without the personal sound amplification smartphone application

Device: Ascending Hearing Technologies device

Interventions

Ascending Hearing Technologies device DEVICE

Personal Sound Amplification Device

Adults with difficulty hearing in some daily listening situations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults who report difficulty hearing in some daily listening situations

You may qualify if:

• Adults who report difficulty hearing in some daily listening situations.
• Primarily English-speaking
• Able to follow instructions and perform study procedures.

You may not qualify if:

• Children
• Non-English speaking
• Unable to perform research procedures and/or follow necessary instructions

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• University of Wisconsin, Milwaukee: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Christina Runge
• Organization: Ascending Hearing Technologies, LLC

chrunge@mcw.edu

2623523478

Study Officials

• Christina L Runge, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 29, 2018
• Study Start: February 26, 2021
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: February 3, 2023
• Results First Posted: February 3, 2023

Record last verified: 2023-01

Locations

US (1)